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Global Linerixibat Itch Study of Efficacy and Safety in Primary Biliary Cholangitis (PBC) (GLISTEN)

CompletedPhase 3

Sponsor: GlaxoSmithKline

Conditions: Pruritus

Interventions: Linerixibat, Placebo

Countries: Germany, United Kingdom

This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male and female participants must be between 18 to 80 years of age inclusive, at the time of signing the informed consent.
* Participants who have documented PBC.
* Participants who have moderate to severe itch.

Exclusion Criteria:

* Total bilirubin \>2.0 times Upper Limit of Normal (ULN) using the average of two Baseline measures.
* Screening Alanine Aminotransferase (ALT) \> 6 times ULN in a single Baseline measure or ALT \> 5 times ULN using the average of two Baseline measures.
* Screening estimated glomerular filtration rate (eGFR) \<30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2).
* History or presence of hepatic decompensation (e.g., variceal bleeding, hepatic encephalopathy or ascites).
* Presence of HBsAg positive hepatitis B or hepatitis C (HCV) (anti-HCV and Ribonucleic acid \[RNA\] detected) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease and/or confirmed hepatocellular carcinoma or biliary cancer.
* Current clinically significant diarrhea or active inflammatory ileal disease according to Investigator´s clinical judgment.
* Current symptomatic cholelithiasis or cholecystitis.
* Current diagnosis of primary skin disorders with itch as a characteristic feature (e.g., atopic dermatitis, psoriasis).
* Primary sleep disorders such as but are not limited to sleep apnea, narcolepsy, hypersomnia.
* Initiation, discontinuation or change in dose of ursodeoxycholic acid (UDCA), bezafibrate or fenofibrate in the 8 weeks prior to Screening.
* Use of obeticholic acid: within 8 weeks prior to Screening. (Participants may not initiate or restart during the study).
* Initiation, discontinuation, or change in dose of any of the following in the 8 weeks prior to Screening: bile acid binding resins, rifampicin, naltrexone, naloxone, nalfurafine, pregabalin, gabapentin, sertraline or other selective serotonin reuptake inhibitor (SSRIs), antihistamines used for the treatment of itching.
* Administration of any other human ileal bile acid transporter (IBAT) inhibitor in the 12 weeks prior to screening.
* Any planned procedures intended to treat cholestatic pruritus such as nasobiliary drainage or ultraviolet light therapy from Screening and throughout the study.
* History of sensitivity or intolerance to the study treatment.

Locations (5)

Erlangen, Germany
Münster, Germany
Cambridge, United Kingdom
Durham, United Kingdom
Newcastle upon Tyne, United Kingdom